(106 days)
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes. The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen. The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible. The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive. The advancer functions as a housing for the air turbine and as for the sliding elements that control burr extension. The console monitors and controls the votational speed of the burr and continuously provides the operator with herformance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange. The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange. The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (HTI Floppy, Floppy II, Standard) | Predicate Performance (Type A, Type C) |
|---|---|---|---|
| Tensile Force (weld joint) | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 315g | |
| Floppy II: 364g | |||
| Standard: 603g | Type A: 182g | ||
| Type C: No Test | |||
| Tensile Force (solder joint) | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 1132g | |
| Floppy II: 1373g | |||
| Standard: 1837g | Type A: 2384g | ||
| Type C: No Test | |||
| Torque Strength (turns to failure) | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 11.6 | |
| Floppy II: 9.7 | |||
| Standard: 15 | Type A: No Test | ||
| Type C: 18.8 | |||
| Torqueability (proximal to distal turns) | A 1:1 torque response is desirable (for one revolution of the proximal end, the distal spring tip in the vessel should also rotate once). | Floppy: 1.75 to 1 | |
| Floppy II: No Test | |||
| Standard: 2 to 1 | Type A: 3.25 to 1 | ||
| Type C: No Test | |||
| Tip Flexibility (a: cantilevered 1.5") | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 15.7 mm | |
| Floppy II: 20.7 mm | |||
| Standard: 14 mm | Type A: 6.0 mm | ||
| Type C: 19.0 mm | |||
| Tip Flexibility (b: cantilevered 3.1") | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 44.0 mm | |
| Floppy II: 47.5 mm | |||
| Standard: No Test | Type A: 25.1 mm | ||
| Type C: 20.0 mm | |||
| Tip Flexibility (c: cantilevered 6.1") | Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates. | Floppy: 97.8 mm | |
| Floppy II: 102.9 mm | |||
| Standard: No Test | Type A: 76.2 mm | ||
| Type C: 71.1 mm | |||
| Wear Test | Success criteria: (1) guide wire does not fail catastrophically, and (2) at the end of a two-minute test, advancer speed ≥ 150,000 RPM. | All wire configurations passed wear test. | Not explicitly stated, implied to be previously met by predicate devices. |
| Heart Model (Qualitative) | N/A (qualitative assessment of pushability and steerability). | All HTI wires were found more maneuverable than the Types A and C. | N/A (predicate served as comparison baseline). |
| Clinical Performance | Complication rates associated with HTI guide wires are not significantly different from Types A and C guide wires (with specified exceptions not related to the guide wire). Safety and efficacy conclusions for coronary use also apply to peripheral use. | Descriptive statistical analysis showed no significant difference in complication rates (with exceptions). One guide wire fracture observed. | Not explicitly detailed but serves as the baseline for comparison. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: 147 sequentially enrolled patients.
- Data Provenance: The study was a clinical investigation conducted between July 1994 and December 1994. It's a prospective study given the enrollment period. The geographic origin is not explicitly stated, but the company is based in Redmond, WA, USA, suggesting a US-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document describes a clinical investigation with patient outcomes and complication rates. The "ground truth" here is the clinical outcome observed in patients during the angioplasty procedure.
- The number and qualifications of clinicians involved in the patient procedures and outcome assessment are not explicitly stated in the provided text.
- The study references "Ellis, et al, Circulation, Vol 89, No 2, Feb 1994. Relation of Clinical Presentation, Stenosis, Morphology, and Operator Technique to the Procedural Results of Rotational Atherectomy Facilitated Angioplasty," suggesting that clinical practice and established medical literature inform the understanding of outcomes.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method for the clinical outcomes. It describes standard clinical follow-up and descriptive statistical analysis of complication rates.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study, as typically understood in AI-assisted diagnostics (i.e., comparing human readers with and without AI assistance), was not performed. This study is for a medical device (guide wire) and focuses on its safety and effectiveness compared to predicate devices, not an AI model's impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is a medical device, not an algorithm. The "standalone" performance refers to the device's intrinsic mechanical properties and clinical outcomes when used by clinicians. The bench tests (tensile force, torque strength, flexibility, wear test) represent aspects of standalone device performance.
7. The Type of Ground Truth Used
- Clinical Outcomes/Patient Data: For the clinical study, the ground truth is based on observed patient outcomes, complication rates, and the assessment of guide wire performance during actual procedures (e.g., guide wire fracture). This includes both objective measures (complication rates) and qualitative clinical assessments (e.g., maneuverability in the heart model).
- Engineering Specifications/Bench Test Results: For the in-vitro tests, the ground truth is the direct measurement of physical properties (e.g., grams of tensile force, turns to failure for torque strength, mm for tip flexibility) under controlled laboratory conditions, against established engineering standards or comparative predicate device performance.
8. The Sample Size for the Training Set
- This pertains to an AI/ML context. Since this is a submission for a physical medical device (a guide wire), there is no "training set" in the AI sense. The design and validation of the guide wire are based on engineering principles (bench testing) and clinical trials, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- As there is no AI training set, this question is not applicable.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).